FDA’s Product Jurisdiction Proposal: More Changes are Needed

Following our blog post on the topic, in which we urged others to comment in response to FDA’s Proposed Product Jurisdiction rule changes, we decided to take our own advice. On July 15, 2018, Hyman, Phelps & McNamara, P.C. filed comments to Docket No. FDA-2004-N-0191.

Our requests were modest but important, and reflect our deep frustrations with the Request for Designation (“RFD”) process as described in previous posts. Specifically, we asked the Agency to (1) establish a timeframe for review of RFD decisions by the Office of Special Medical Programs when requested by the sponsor, pursuant to 21 C.F.R. § 10.75, and (2) remove the 15-page limitation for RFDs at 21 C.F.R. § 3.7. These requested changes would help streamline the RFD process and make it work better for both sponsors and the Agency.

The lack of any timeframe for review of RFD appeals can result in appeals languishing for many months. This delays sponsors from seeking product approval, and may consequently deprive the public of beneficial products for months or years. The current 15-page limitation also frustrates both the Agency’s and sponsors’ goals by stymieing the free exchange of relevant information about a proposed product. Fifteen pages is simply not enough to provide FDA with all the requested information for an RFD, especially as FDA continues to place an increasingly high burden on sponsors to establish a product’s mode of action.

In addition to these requests, we asked FDA to reconsider its approach to determining whether a product or product component achieves its primary intended purposes through chemical action, thereby excluding it from the statutory device definition. FDA alluded to this topic in its proposal, but then proposed no changes. In our experience, FDA’s current approach can wrongly result in a combination product that exhibits very minimal chemical action being regulated as a drug or biologic rather than a device. This approach – which we have seen repeatedly – is not consistent with the statutory language and should be revisited, particularly in light of the 21st Century Cures Act. Comments filed by the Washington Legal Foundation demonstrate why FDA needs to modify the way in which it makes these jurisdictional decisions.